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Stay abreast of all pertinent regulatory affairs issues, including MDCG guidance. QualificationsKnowledge, Skills, and Abilities:Experience with EU MDR CEPs/CER; experience with literature analysis; experience with managing a writing project from start to endCross functional understanding of Design Control and Clinical Affairs.
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This role is an opportunity for an experienced Clinical Operations Professional with technical expertise supporting Phase I-III clinical trials in an industry setting and a strong knowledge of clinical operations, Good Clinical Practice (GCP), and U.S. Food and Drug Administration (FDA) regulatory requirements.
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In addition to its partnership with BP Pulse, FreeWire and AM/PM, a BP subsidiary and convenience store chain with over 1,000 locations, have already deployed multiple public charging stations in the U.S. FreeWire’s regulatory affairs and policy team keeps customers up to date on federal, state, and utility incentive opportunities, which in some cases cover up to 80% of the cost of the charging station, and the company recently announced that the Boost Charger is Buy America compliant.
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We are seeking a Principal Regulatory Affairs Specialist to join Abbott's Heart Failure Division on-site in Pleasanton, CA. As an experienced individual contributor, a Principal Regulatory Affairs Specialist is to provide support for the regulatory department, ensuring efficient and compliant business processes and environment.
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With strong commercial lending and credit experience within the Middle Market to provide top notch customer service to our clients and customers in Fremont, CA. This role focuses on overseeing, leading, and directing a banking branch with regards to sales, operations, and corporate/regulatory compliance to meet assigned lending, deposit, and fee income goals along with business and consumer lending.
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This individual will be responsible for providing operational management to develop, implement, and manage Quality Systems compliant with regulatory requirements, lead cross-functional teams, lead the process on design controls related to quality and process, risk management activities, complaint handling, CAPA, document control, supplier qualification and management, and auditing.
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Communicate changes to the detailing team and reconcile all resulting structural detail changes with all team members Organize detailing RFI’s and create formal RFI’s for review by the engineer, architect, and general contractor Communicate with off-site detailing subcontractors to ensure quality drawings are delivered on time Review and submittal of shop drawings created by steel detailers Assist project manager in management of subcontractors, including metal deckers, miscellaneous steel, etc.
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Knowledge of JIRA issue and project tracking and confluenceteam workspace applicationsExperience and application of competitive analysis toolsExperience with EDA debug tools. SiemensEDA is looking for a highly motivated Product Manager to help define, promote,and deploy solutions for hardware-assisted verification.
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A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.
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Molex is seeking a dynamic and proactive Account Manager to join our highly visible team in the Silicon Valley area to support one of our top global high-tech device accounts while working for one of the top interconnect solutions in the world.
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Technical Project Manager V. 8+ years of experience as Technical Analyst supporting and implementing large scale IT solutions including software deployment, business analysis, project management, process improvement and computer systems validation.
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Are you seeking an engaging legal role that focuses on trade compliance and regulatory affairs? Explore exciting opportunities to work in-house with JDHuntr in the legal field across different locations, including California, Washington DC, Florida, and New York. Discover fulfilling roles as a Corporate Counsel or Lawyer in various cities such as Los Angeles, New York, and San Francisco.
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Monitor international related global legislative and regulatory changes; assess and advise management on tax impacts to Workday’s operations. Hands-on managerial abilities with strong project management, organizational and execution skills.
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Knowledge of regulatory requirements and compliance frameworks (e.g., GDPR, HIPAA). Bachelor's degree in Computer Science, Information Security, or a related field; relevant certifications (e.g., CISSP, CISM, CompTIA Security+) preferred.
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Provide leadership and strategic guidance to support critical projects and programs, including but not limited to: system consolidation and/or upgrades, gross margin and customer/vendor reporting fidelity, product initiatives and integration, management and/or external reporting changes and improvements, and regulatory and tax compliance needs.
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regulatory affairs jobs Title: regulatory affairs project manager Company: Gpac in Fremont, CA
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